Oral administration formulation of blueberry extract as a coadjuvant for preserving the health of human precorneal film

Abstract

The invention relates to a nutraceutical formulation of blueberry extract, fish oil (omega-3 and omega-6), recombinant human lactoferrin, vitamin A and vitamin E, for human oral consumption. The invention belongs to the field of ophthalmology and has been developed as a coadjuvant for preserving the health of the precorneal film and of the eye surface. This formulation contains an extract of natural origin ( Vaccinium myrtillus L) with antioxidant and anti-inflammatory properties; it also uses eicosapentaenoic acid (EPA), omega-6, and docosahexaenoic acid (DHA), omega-3, obtained from fish oil and which, together with lactoferrin, vitamin A and vitamin E, improves tear quality, since these compounds have anti-microbial and anti-inflammatory effects. This formulation has been designed as a coadjuvant for preserving the health of the precorneal film. No formulation for oral administration of a blueberry extract together with lactoferrin, in combination with vitamin A, vitamin E and fish oil (eicosapentaenoic acid and docosahexaenoic acid) is found in the prior art, nor is the use of this formulation as an adjuvant for preserving the health of the precorneal film and/or the eye surface.

We claim: 
     
       1. A method to improve the health of precorneal tear film of the patient in need thereof, comprising the steps of:
 orally administering to the patient a food supplement formulation comprising:
 a. blueberry extract; 
 b. eicosapentaenoic acid (EPA) omega; 
 c. docosahexaenoic acid (DHA) omega-3; 
 d. recombinant human lactoferrin covalently bound directly to one or more polyethylene glycol moieties; 
 e. Vitamin E; 
 f. Vitamin A; and 
 g. an excipient; 
 
 wherein said food supplement formulation is an adjuvant; 
 wherein said excipient is a surfactant that promotes the formation of micelles; and 
 wherein said food supplement formulation is encapsulated with a colloidal gel that is soft gelatin. 
 
     
     
       2. The method according to  claim 1 , wherein the amount of blueberry extract in the food supplement formulation is between 10 mg and 1,000 mg. 
     
     
       3. The method according to  claim 1 , wherein the amount of eicosapentaenoic acid (EPA) omega-6 in the food supplement formulation is between 9,000 mg and 12,000 mg. 
     
     
       4. The method according to  claim 1 , wherein the amount of docosahexaenoic acid (DHA) omega-3 in the food supplement formulation is between 6,000 mg and 8,000 mg. 
     
     
       5. The method according to  claim 1 , wherein the amount of recombinant human lactoferrin in the food supplement formulation is between 100 mg and 500 mg. 
     
     
       6. The method according to  claim 5 , wherein the recombinant human lactoferrin in the food supplement formulation is modified with polyethylene glycol, chitosan or a combination thereof. 
     
     
       7. The method according to  claim 1 , wherein the amount of Vitamin E in the food supplement formulation is 100 UI (unidad internation or international unit) to 400 UI (unidad internation or international unit). 
     
     
       8. The method according to  claim 1 , wherein the amount of Vitamin A in the food supplement formulation is 500 UI (unidad internation or international unit) to 1,500 UI (unidad internation or international unit). 
     
     
       9. The method according to  claim 1 , wherein the food supplement weighs approximately 100 g. 
     
     
       10. The method according to  claim 1 , wherein said blueberry extract is selected from the  Vaccinium myrtillus  L species.